Device and method for allografting

ABSTRACT

In one embodiment, a cutting guide is disclosed for use in a surgical procedure to removed damaged tissue from a patient and form a recipient site configured and dimensioned to receive a donor graft. The cutting guide includes a first aim that abuts a section of the damaged tissue to be removed, and a second arm including a hole and a slot that receives a cutting implement, the first arm and the slot defining a distance therebetween corresponding to a desired dimension of the recipient site. In another embodiment, a cutting guide is disclosed for use in forming a donor graft from donor tissue. The cutting guide includes a body that receives the donor tissue, and a shaping member that is rotatably secured to the body. The shaping member includes at least one vane that shapes the donor tissue so as to form the donor graft.

RELATED APPLICATION

This application claims the benefit of, and priority to, U.S.Provisional Patent Application Ser. No. 61/967,257, entitled “Device andMethod for Tibial Plateau Allografting,” filed Mar. 13, 2014, the entirecontent of which is hereby incorporated by reference.

BACKGROUND 1. Field

The present disclosure relates to apparatus, systems, and methods foruse in tissue grafting procedures, e.g., allografting procedures. Forexample, the present disclosure relates to apparatus, methods, andsystems for use in tibial plateau allografting procedures.

2. Discussion

Few options are available for long term treatment of tibial plateauarticular cartilage and/or meniscal injuries, e.g., in young patients,which due to trauma or degeneration, render the joint painful,insufficient, and beyond the ability of native tissue repair techniques.Current standard of care allograft and/or autograft cartilagetransplantation techniques are sometimes inappropriate or unable toaddress tibial plateau cartilage defects, e.g., due to limitations ofsurgical exposure and current grafting techniques. Additionally,meniscus positioning and attachment to the tibia limits surgical optionswithout disruption of the meniscus. Moreover, during meniscaltransplantation, it is often difficult to establish an effectivemeniscus-bone interface with properties sufficient to withstandphysiological loading due to the complex biologic and biomechanicalnature of the interface.

As such, a need remains for apparatus, systems, and methods that aid inthe graft implantation process, and have sufficient healing andfunctional performance to be utilized in a wide range of patients withjoint pathology.

SUMMARY

In one aspect of the present disclosure, an allograft tibial plateauimplant system is described, as well as corresponding methods of use,that utilize a tongue-and-groove interlocking mechanism. Morespecifically, the disclosed system and methods create and use anallograft tibial plateau implant with a bulging outward-curved ledge(tongue member) that is received by an implant recipient site preparedwith a matching inward-curved groove/channel (groove member). This“tongue-and-groove” interlocking system and method may be utilized in awide range of patients with joint pathology to enhance healing andfunctional performance.

In another aspect of the present disclosure, a recipient site cuttingguide for preparing a recipient site in tissue is described. Therecipient site cutting guide comprises a height-determination (H-G) armand a blade arm with a cutting slot, one or more guide holes, and one ormore fixation holes. In one embodiment, the height-determination (H-G)arm and the blade arm are arranged so as to define an “L” shape. Theconfigurations, dimensions, and orientations of the cutting slot, theguide hole(s), and the fixation hole(s) may be altered or varied suchthat the recipient site may be created according to any desiredspecifications, e.g., such that the recipient site and thegroove/channel define a particular length, height, and/or width.

In certain embodiments, the cutting slot may be configured as anelongate cavity running horizontally, e.g., more than half-way, acrossthe blade arm in parallel relation to the height-determination (H-G)arm.

In certain embodiments, the guide hole(s) may be located near an end ofthe cutting slot, and a bottom curve/edge of the guide hole(s) may beset lower than the cutting slot.

In certain embodiments, the fixation hole(s) may be located below thecutting slot (on an opposite side of the height-determination (H-G)arm).

During use of the recipient site cutting guide, the height-determination(H-G) arm is placed on a surface of a patient's articular cartilage suchthat the distance between the height-determination (H-G) arm and thecutting slot on the blade arm determines the height of recipient site toreceive a harvested allograft implant.

Multiple cutting guides defining varying distances between theheight-determination (H-G) arm and the cutting slot may be employed tocreate recipient sites of varying heights to accommodate differentgrafting requirements.

In another aspect of the present disclosure, a method of preparing arecipient site, e.g., a patient's tibial plateau, for receipt of anallograft is disclosed (which may comprise bone and articularcartilage), with or without attached meniscus. The method includes: i)selecting a recipient site cutting guide with a desired distance beingdefined between a height-determination (H-G) arm and a cutting slot, ii)placing the height-determination (H-G) arm on a surface of the patient'sarticular cartilage, iii) securing the recipient site cutting guide bytemporary fixation methods via one or more fixation holes; iv) making ashelf locating cut from anterior to posterior in a central aspect of therecipient bone; and v) cutting along the cutting slot to detach aportion of the recipient bone to be removed.

In another aspect of the invention, a method for preparing an allograftrecipient site, e.g., a patient's tibial plateua, is described. Themethod includes: i) selecting a recipient site cutting guide comprisinga H-G arm and a blade arm, which further comprises a cutting slot, oneor more guide holes with a slot or other such opening, and one or morefixation holes, so that the height between the H-G arm and the cuttingslot is compatible with the allograft to be implanted, ii) placing theH-G arm of the cutting guide on a surface of the patient's articularcartilage, iii) securing the cutting guide by temporary fixation methodsvia the fixation hole(s), iv) creating a channel from anterior toposterior by drilling (or forming a channel) through the guide hole(s),and v) removing a portion of the native tibial plateau by cutting alongthe cutting slot.

In another aspect of the present disclosure, a donor cutting guide isdisclosed that is used to create an allograft implant (which maycomprise bone and articular cartilage), with or without an attachedmeniscus, having a desired thickness and a bulging outward-curved ledge(tongue member) that is configured and dimensioned for positioningwithin the groove/channel (groove member) created at the recipient sitethrough use of the recipient site cutting guide.

In another aspect of the disclosure, a cutting guide is disclosed foruse in a surgical procedure to removed damaged tissue from a patient andform a recipient site configured and dimensioned to receive a donorgraft. The cutting guide includes a first arm configured and dimensionedfor abutment with a section of the damages tissue to be removed, and asecond aim connected to the first arm.

The second arm includes at least one slot that is configured anddimensioned to receive a first cutting implement, as well as at leastone hole. The first arm and the at least one slot define a distancetherebetween corresponding to a desired dimension of the recipient site,e.g., the height of the recipient site.

In certain embodiments, the first arm and the second arm may subtend anangle approximately equal to 90°.

The at least one hole includes a first hole that is configured anddimensioned to receive a second cutting implement. The first holedefines a periphery, and is positioned adjacent an end of the at leastone slot.

In certain embodiments, a portion of the periphery defined by the firsthole may be positioned below the at least one slot. Additionally, oralternatively, a portion of the periphery defined by the first hole maybe positioned above the at least one slot.

In certain embodiments, the at least one slot and the first hole may beoriented such that a central axis defined by the at least one slotbisects the first hole.

In certain embodiments, the at least one hole may further include asecond hole that is configured and dimensioned to receive a fixationmember to secure the cutting guide in relation to the damaged tissue.

In certain embodiments, the at least one slot may be linear inconfiguration.

In certain embodiments, the at least one slot may include a first slotand a second slot. In such embodiments, the first arm and the first slotdefine a first distance therebetween, and the first arm and the secondslot define a second distance therebetween greater than the firstdistance.

In another aspect of the disclosure, a surgical cutting guide isdisclosed for use in forming a donor graft from donor tissue. Thecutting guide includes a body defining a channel extending along a firstaxis that is configured and dimensioned to receive the donor tissue, anda shaping member that is secured to the body such that the shapingmember is rotatable in relation to the body about a second axis.

The body of the cutting guide defines an upper shelf and a lower shelfpositioned on opposite sides of the shaping member.

The shaping member includes at least one vane having a linear portionand a non-linear portion, and extends into the channel such that as thedonor tissue is advanced through the channel, the at least one vaneshapes the donor tissue so as to form the donor graft.

In certain embodiments, the shaping member may be secured to the body ofthe cutting guide such that the second axis is transverse, e.g.,orthogonal, in relation to the first axis.

The linear portion and the non-linear portion of the at least one vaneare configured and dimensioned such that the donor graft defines aplanar section and a tongue member positioned adjacent the planarsection such that the tongue member extends outwardly in relation to theplanar section.

In certain embodiments, the non-linear portion of the at least one vanemay define at least one recess.

The cutting guide further includes a sled movable in relation to thebody of the cutting guide to facilitate movement of the donor tissuethrough the channel.

In certain embodiments, the sled may include a textured surface toincrease friction between the sled and the donor tissue during movementof the donor tissue through the channel.

In another aspect of the disclosure, a surgical system is disclosed foruse in: (i) forming a donor graft from donor tissue; and (ii) removingdamaged tissue from a patient to form a recipient site configured anddimensioned to receive the donor graft. The system includes a firstcutting guide configured and dimensioned to form the donor graft fromthe donor tissue, and a second cutting guide configured and dimensionedto facilitate formation of the recipient site.

The first cutting guide includes a body defining a channel that isconfigured and dimensioned to receive the donor tissue, and a shapingmember that is secured to the body such that the shaping member isrotatable in relation to the body.

The shaping member includes at least one vane having a linear portionand a non-linear portion, and extends into the channel whereby as thedonor tissue is advanced through the channel, the at least one vaneshapes the donor tissue to form the donor graft to include a planarsection and a tongue member that extends outwardly in relation to theplanar section.

The second cutting guide includes a first aim that is configured anddimensioned for abutment with a section of the damaged tissue to beremoved, and a second arm that is connected to the first arm. The secondarm includes at least one slot that is configured and dimensioned toreceive a first cutting implement so as to define a planar surface atthe recipient tissue corresponding in configuration and dimensions tothe planar section of the donor graft. The second arm also includes atleast one hole that is configured and dimensioned to receive a secondcutting implement so as to define a channel at the recipient siteconfigured and dimensioned to receive the tongue member of the donorgraft such that the recipient site receives the donor graft in aninterlocking fashion.

In certain embodiments, the first arm and the second arm may subtend anangle of approximately 90°.

The at least one hole includes a first hole defining a periphery that ispositioned adjacent an end of the at least one slot.

In certain embodiments, a portion of the periphery defined by the firsthole is positioned below the at least one slot.

In certain embodiments, the at least one hole includes a second holeconfigured and dimensioned to receive a fixation member to secure thesecond cutting guide in relation to the damaged tissue.

The channel defined by the body of the first cutting guide extends alonga first axis, and the shaping member is rotatable in relation to thebody of the first cutting guide about a second axis. In certainembodiments, the shaping member may be secured to the body of the firstcutting guide such that the second axis is transverse, e.g., orthogonal,in relation to the first axis.

The linear portion of the at least one vane is configured anddimensioned to shape the planar section of the donor graft, and thenon-linear portion of the at least one vane is configured anddimensioned to shape the tongue member of the donor graft.

In certain embodiments, the non-linear portion of the at least one vanemay define at least one recess.

In certain embodiments, the at least one recess may be curvate inconfiguration.

In another aspect of the disclosure, a method of performing a surgicalprocedure is disclosed that includes inserting donor tissue into a donorcutting guide, which may include bone and cartilage, as well as anattached meniscus, and advancing the donor tissue into contact with ashaping member rotatably secured to a body of the donor cutting guidesuch that a vane of the shaping member shapes the donor tissue into adonor graft including a planar section and a tongue member that extendsoutwardly in relation to the planar section.

In certain embodiments, the method may further include harvesting thedonor tissue from a donor site.

In certain embodiments, harvesting the donor tissue may includeharvesting the donor tissue with an attached meniscus.

Inserting the donor tissue into the donor cutting guide includespositioning the donor tissue within a channel defined by the body of thedonor cutting guide, and more specifically, on a lower shelf defined bythe body of the donor cutting guide.

The disclosed method further includes advancing the donor tissue beyondthe shaping member such that the donor tissue is positioned on an uppershelf defined by the body of the donor cutting guide after shaping intothe donor graft.

Advancing the donor tissue includes repositioning a sled in contact withthe donor tissue to thereby reposition the donor tissue.

Advancing the donor tissue into contact with the shaping member includesshaping a first portion of the donor tissue with a linear portion of thevane to thereby form the planar section of the donor graft, and shapinga second portion of the donor tissue with a non-linear portion of thevane to thereby form the tongue member of the donor graft.

In certain embodiments, shaping the second portion of the donor tissuemay include shaping the donor tissue with a recess defined by the vane.

In certain embodiments, shaping the donor tissue with the recess mayinclude contacting the donor tissue with an arcuate surface defined bythe recess.

The method further includes removing damaged tissue from a patient tofaun a recipient site configured and dimensioned to receive the donorgraft in an interlocking fashion.

Forming the recipient site includes positioning a first arm of arecipient cutting guide in abutment with a section of the damaged tissueto be removed, and a second arm of the recipient cutting guide inabutment with a section of tissue that will not be removed.

In certain embodiments, forming the recipient site may further includesecuring the recipient cutting guide in relation to the damaged tissue,e.g., via attachment of a fixation member to the tissue that will not beremoved through a hole in the recipient cutting guide.

Forming the recipient site further includes forming a channel configuredand dimensioned to receive the tongue member of the donor graft, e.g.,by passing a cutting implement through a hole in the recipient cuttingguide.

Forming the recipient site further includes making a cut that intersectsthe channel so as to form a planar surface at the recipient siteconfigured and dimensioned for engagement with the planar section of thedonor graft, i.e., by passing a cutting implement through a slotextending through the second aim of the recipient cutting guide.

The method further includes positioning the donor graft such that thedonor graft interlocks with the recipient site, e.g., such that thetongue member of the donor graft is positioned within the channel at therecipient site.

In certain embodiments, the method may further include securing thedonor graft to the recipient site.

Other objects, features, and advantages of various illustrativeembodiments of the present disclosure will become apparent withreference to the accompanying drawings, and the detailed descriptionthat follows.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure are described herein withreference to the figures, wherein:

FIG. 1 is a front, elevational view illustrating a recipient cuttingguide according to the principles of the present disclosure useful inthe removal of damaged tissue, e.g., bone and cartilage, and theformation of a recipient site configured and dimensioned to receive adonor graft;

FIG. 2 is a side, elevational view of the presently disclosed recipientcutting guide;

FIG. 3 is a side, elevational view of a donor graft following theremoval of damaged tissue and formation of the recipient site;

FIG. 4 is a top, perspective view of the recipient site;

FIG. 5 is a side, elevational view illustrating placement of the donorgraft at the recipient site;

FIG. 6 is a top, perspective view illustrating placement of the donorgraft at the recipient site;

FIG. 7 is a side, elevational view of the presently disclosed recipientcutting guide;

FIG. 8 is a front, elevational view of the presently disclosed recipientcutting guide;

FIGS. 9 and 10 are top, perspective views of the presently disclosedrecipient cutting guide;

FIGS. 11 and 12 are bottom, perspective views of the presently disclosedrecipient cutting guide;

FIG. 13 is a side, elevational view of an alternate embodiment of thepresently disclosed recipient cutting guide;

FIG. 14 is a top, perspective view of the recipient cutting guide shownin FIG. 13;

FIG. 15 is a top, perspective view of a donor cutting guide useful informing the donor graft shown in FIG. 3 from donor tissue;

FIG. 16 is an end view of the presently disclosed donor cutting guideand the donor tissue;

FIG. 17 is a longitudinal, cross-sectional view of the presentlydisclosed donor cutting guide and the donor tissue;

FIG. 18 is a partial, end view of the presently disclosed donor cuttingguide;

FIG. 19 is a side, elevational view illustrating a shaping member of thepresently disclosed donor cutting guide; and

FIG. 20 is a partial, end view illustrating a sled of the presentlydisclosed donor cutting guide together with the donor tissue.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which depict non-limiting, illustrativeembodiments of the present disclosure. Throughout the presentdisclosure, the term “tissue” should be understood as including manyforms of biological structural material, including, but not limited to,bone and cartilage. Additionally, the term “damaged tissue” should beunderstood to encompass any negatively affected tissue, including, butnot limited to inflamed tissue, scarred tissue, and joint pathology.Additionally, the terms “height,” “width,” “thickness,” “above,”“below,” “closer,” “further,” and any variation(s) thereof used hereinare relative in character, and are intended to be interpreted inaccordance with the perspective shown in the corresponding figure(s).

The present disclosure relates to apparatus, systems, and methodsadapted for use in grafting procedures, e.g., tibial plateauallografting (with or without attached meniscus), and provides numerousbenefits over known apparatus, systems, and methods. For example, theapparatus, systems, and methods disclosed allow for maintenance of themeniscus/bone junction, and facilitate transplantation of healthycartilage and a healthy meniscus as a unit, as opposed to beingtransplanted separately. Moreover, the apparatus disclosed hereinminimize the amount of native tissue that is removed to form therecipient site, while still allowing for appropriate fixation of thedonor graft.

With reference now to FIGS. 1-12, a cutting guide 10 is illustrated foruse during a surgical procedure in the preparation of a recipient site 5(FIGS. 3-6) in tissue 2, e.g., a patient's tibial plateau, to receive adonor graft 1, e.g., a tibial plateau allograft, and the removal ofdamaged tissue.

The recipient site cutting guide 10 may include, e.g., be formed from,any material suitable for use in surgical practice, e.g., plastics,polymers, aluminum, stainless steel, titanium, and combinations thereof,and includes a generally horizontal first arm, e.g., aheight-determination (H-G) arm, identified by the reference character20, and a generally vertical second aim, e.g., a blade aim, identifiedby the reference character 30. In the illustrated embodiment, the arms20, 30 are integrally, e.g., monolithically, formed. In alternateembodiments, however, other suitable methods of attachment may beemployed to connect the arms 20, 30, e.g., one or more connectors orfasteners may be employed, or the arms 20, 30 may be welded together.

The arms 20, 30 are connected such that the cutting guide 10 defines agenerally “L-shaped” configuration, e.g., such that the arms 20, 30subtend a fixed angle α (FIG. 7) of approximately 90°, e.g., 60°-120°.In alternate embodiments, however, if necessary or desirable, theconfiguration of the cutting guide 10 may be varied to alter the angleα. For example, the arms 20, 30 may be arranged such that the angle αlies outside the range of 60°-120° dependent upon the requirements of aparticular surgical procedure. Additionally, it is envisioned that thearms 20, 30 may movably connected to one another such that the angle αmay be adjusted by the user on an as-needed basis, e.g., during thecourse of a surgical procedure.

The second arm 30 includes a cutting slot 40, one or more guide holes,50, and one or more fixation holes 60. Although illustrated as includinga single cutting slot 40, a single guide hole 50, and a pair of fixationholes 60 in the embodiment illustrated in FIGS. 7-12, the number ofcutting slots 40, guide holes 50, and fixation holes 60 may be varied inalternate embodiments of the cutting guide 10 without departing from thescope of the present disclosure.

The cutting slot 40 extends horizontally across the second arm 30, andis configured and dimensioned to receive a cutting implement, e.g., asagittal saw (not shown). In the illustrated embodiment, the cuttingslot 40 and the first arm 20 are shown as extending in parallelrelation, i.e., along non-intersecting axes. In alternate embodiments,however, the cutting slot 40 and the first arm 20 may be arranged so asto extend along intersecting axes. Additionally, while the cutting slot40 is illustrated as being linear in configuration in the embodimentshown in FIGS. 7-12, in alternate embodiments, the cutting slot 40 maybe non-linear in configuration. For example, the cutting slot 40 mayinclude one or more arcuate and/or linear segments or sections.

The first arm 20 and the cutting slot 40 define a distance D (FIG. 7)therebetween that determines the vertical height (thickness) of therecipient site 5 (FIGS. 3-6), as discussed in further detail below. Ingeneral, the distance D will lie within the range of approximately 2 cmto approximately 20 cm (±25%). In most surgical applications, however, adistance D of approximately 6 cm to approximately 10 cm is standard.

The guide hole 50 is located adjacent an end of the cutting slot 40, anddefines a periphery P (FIG. 8). Although illustrated as being separatedfrom the cutting slot 40, i.e., such that there is not communicationbetween the guide hole 50 and the cutting slot 40, in alternateembodiments, the guide hole 50 and the cutting slot 40 may intersect.Additionally, while illustrated as circular in configuration in FIGS.7-12, the guide hole 50 may define alternate configurations in otherembodiments of the cutting guide 10, e.g., the guide hole 50 may beelliptical, ovoid, rectangular, etc.

As seen in FIG. 8, for example, the guide hole 50 and the cutting slot40 are oriented such that an upper portion of the periphery P of theguide hole 50 is located above the cutting slot 40 (closer to the firstarm 20), and a lower portion of the periphery P of the guide hole 50 islocated below the cutting slot 40 (further from the first arm 20). Forexample, it is envisioned that a central axis X_(CS) (FIG. 8) of thecutting slot 40 may bisect the guide hole 50.

With continued reference to FIGS. 7-12, the fixation holes 60 will bediscussed. The fixation holes 60 are configured and dimensioned toremovably receive fixation members (not shown), e.g., pins, screws,nails, or the like, which can be used to secure the cutting guide 10 tothe tissue 2 (FIGS. 3-6), e.g., tibial bone, in which the recipient site5 is formed, as discussed in further detail below. In the illustratedembodiment, the fixation holes 60 are located below the cutting slot 40.In alternate embodiments, however, the specific location of the fixationholes 60 may be altered or varied. For example, in one embodiment, it isenvisioned that the fixation holes 60 may be located above the cuttingslot 40, whereas in another embodiment, it is envisioned that thecutting guide 10 may include one fixation hole 60 located above thecutting slot 40, and another fixation hole 60 located below, or in linewith, the cutting slot 40.

Although illustrated as being circular in configuration in theembodiment of the cutting guide 10 shown in FIGS. 7-12, the fixationholes 60 may define alternate configurations in other embodiments of thepresent disclosure. For example, the fixation holes 60 may beelliptical, ovoid, rectangular, etc.

With reference now to FIGS. 1-12, use of the recipient site cuttingguide 10 will be discussed in connection with the removal of damagedtissue, and formation of the recipient site 5 (FIGS. 3-6) in preparationto receive a donor graft 1.

Initially, the recipient site cutting guide 10 is selected according tothe requirements of the procedure, e.g., such that the dimensionsdefined by the recipient site 5 correspond to those of the donor graft1, which may include an attached meniscus 4, as seen in FIGS. 3, 5, and6. For example, the recipient site cutting guide 10 may be selectedbased upon the distance D (FIG. 7) defined between the first arm 20 andthe cutting slot 40 such that the recipient site 5 is dimensioned todefine a particular height in correspondence with the height (thickness)of the donor graft 1. The selected recipient site cutting guide 10 isthen positioned such that the first arm 20 abuts a portion 3 _(A) (FIG.2) of the tissue 2 to be removed, i.e., damaged tissue, located abovethe cutting slot 40, and the second arm 30 abuts a portion 3 _(B) of thetissue 2 that will not be removed, located below the cutting slot 40.The configuration and dimensions of the recipient site cutting guide 10,e.g., the location and dimensions of the cutting slot 40, are such thatthe amount of native tissue 2 removed to form the recipient site 5 isminimized, while still allowing for appropriate fixation of the donorgraft 1.

After positioning the recipient site cutting guide 10, the cutting guide10 is then secured to the tissue 2 by fixation members (not shown)inserted through the fixation holes 60. Alternatively, the user maysimply apply pressure to the recipient site cutting guide 10 to hold therecipient site cutting guide 10 in place.

Thereafter, a drill bit (not shown), or other such cutting implement, isinserted into, and advanced through, the guide hole 50 into contact withthe tissue 2 to create a channel 6 (FIGS. 3, 4), e.g., from anterior toposterior. A cut is then made along the cutting slot 40 using a saggitalsaw (not shown), or other such cutting implement, until the channel 6 isreached so as to define an upper surface 7 of the recipient site 5. Forexample, with reference to FIGS. 1-6 in particular, due to the linearconfiguration of the cutting slot 40 included in the cutting guide 10,the cut made in the tissue 2 results in a planar configuration at theupper surface 7 of the recipient site 5. In alternate embodiments,however, i.e., embodiments wherein the cuttings slot 40 is non-linear inconfiguration, the upper surface 7 of the recipient site 5 may be formedso as to define a non-planar, or otherwise irregular configuration.

After completion of the cut, the cutting implement is removed from thecutting slot 40, the fixation members (not shown) can be removed fromthe fixation holes 60, and the portion 3 _(A) (FIG. 2) of the tissue 2to be removed can be separated from the remainder of the tissue 2,revealing the recipient site 5, including the aforementioned channel 6and upper surface 7.

FIGS. 13 and 14 illustrate an alternate embodiment of the presentlydisclosed recipient site cutting guide, which is referred to generallyby the reference character 110. The cutting guide 110 is identical tothe cutting guide 10 discussed above in connection with FIGS. 7-12, forexample, hut for any distinctions that are specifically noted.Accordingly, a discussion of certain features common to the cuttingguides 10, 110 may be omitted in the interest of brevity.

To increase versatility of the cutting guide 110, and the creation ofrecipient sites 5 (FIGS. 3-6) of various dimensions, e.g., heights, thecutting guide 110 includes a first arm 120, and a second arm 130 with aseries of cutting slots 140, each of which is located a differentdistance from the first arm 120. For example, in the embodimentillustrated in FIGS. 13 and 14, the second aim 130 includes cuttingslots 140 _(A), 140 _(B), 140 _(C), wherein the first arm 120 is spaceda distance D_(A) from the cutting slot 140 _(A), a distance D_(B) fromthe cutting slot 140 _(B) greater than the distance D_(A), and adistance D_(C) from the cutting slot 140 _(C) greater than the distanceD_(B).

The method of using the cutting guide 110 is identical to that of thecutting guide 10, but for the fact that the user has the ability tochoose a specific cutting slot, e.g., one of the cutting slots 140 _(A),140 _(B), 140 _(C) in the embodiment shown in FIGS. 13 and 14, basedupon the requirements of the particular procedure. For example,dependent upon the characteristics of the patient, and/or those of thedamaged tissue to be removed, the user may elect to use one of thecutting slots 140 _(A), 140 _(B), 140 _(C) as opposed to another toguide the cutting implement during formation of the upper surface 7(FIGS. 3-7) of the recipient site 5.

In an alternate method of use, it is envisioned that more than one ofthe cutting slots 140 _(A), 140 _(B), 140 _(C) may be employed during asurgical procedure. For example, an initial cut may be made using thecutting slot 140 _(A), and thereafter, one ore more additional cuts maybe made using the cutting slot 140 _(B) and/or the cutting slot 140 _(C)to allow for the progressive removal of the tissue and definition of therecipient site 5, e.g., to reduce patient trauma and/or inflammation atthe recipient site 5.

With reference now to FIGS. 15-20, a donor implant cutting guide 200will be discussed useful in formation of the aforementioned donor graft1 (FIGS. 3-6, 15). The cutting guide 200 may include, e.g., be formedfrom, any material suitable for use in surgical practice, e.g.,plastics, polymers, aluminum, stainless steel, titanium, andcombinations thereof, and includes a body 202, a shaping member 204, anda movable sled 206.

The body 202 of the cutting guide 200 defines a channel 208 that isconfigured and dimensioned to receive donor tissue T, which may includean attached meniscus 4 (FIGS. 3, 5, 6, 15, 16). The channel 208 extendsalong an axis X, and is defined by sidewalls 210, 212, and respectivelower and upper shelves 214, 216 positioned on opposite sides of theshaping member 204. The lower shelf 214 is spaced a first distance D₁(FIG. 17) from a bottom wall 218 of the body 202, and the upper shelf216 is spaced a second, greater distance D₂ from the bottom wall 218 ofthe body 202.

Although illustrated as extending in parallel relation to the bottomwall 218 of the body 202 in the embodiment illustrated in FIGS. 15-20,in alternate embodiments of the cutting guide 200, the shelf 214 and/orthe shelf 216 may extend at an angle to the bottom wall 218 so as toeither assist or resist movement of the donor tissue T through thechannel 208. For example, either or both of the shelves 214, 216 may beangled toward the shaping member 204, or away from the shaping member204.

The shaping member 204 resides within a well 220 defined by the body202, and is secured to the body 202 such that the shaping member 204 isrotatable in relation to the body 202 about a fixed axis Y (FIG. 15)that extends in transverse relation to the axis X defined by the channel208. For example, in the embodiment seen in FIG. 15, the shaping member204 is oriented such that the axis Y is orthogonal in relation to theaxis X. In alternate embodiments, however, the shaping member 204 may beoriented such that the axes X, Y subtend an angle other than 90°, e.g.,45°.

The shaping member 204 may be actuated, i.e., caused to rotate, by anautomated mechanism, e.g., a motor (not shown), or alternatively, undermanual power via the application of force by a user. For example, theshaping member 204 may be rotated by a crank (not shown) connected tothe shaping member 204.

The shaping member 204 includes a drum 222, and one or more vanes 224.While the vanes 224 may include sharpened cutting edges 226 (FIGS. 18,19), as illustrated in the embodiment seen in FIGS. 15-20, the vanes 224may be devoid of any sharpened edges in alternate embodiments of thecutting guide 200. Additionally, while the shaping member 204 isillustrated as including four (4) vanes 224 in the embodiment of thecutting guide 200 shown in FIGS. 15-20, the number of vanes 224 may beincreased or decreased in alternate embodiments of the cutting guide 200without departing from the scope of the present disclosure, e.g., toreduce manufacturing costs.

The vanes 224 extend outwardly from the drum 222 into the channel 208.Specifically, the shaping member 204 is positioned within the well 220such that the edges 226 of the vanes 224 align with the upper shelf 216,i.e., such that the maximum linear separation realized between the vanes224 and the bottom wall 218 of the body 202 during rotation of theshaping member 204 is equivalent to the distance D₂ (FIG. 17) definedbetween the upper shelf 216 and the bottom wall 218.

The vanes 224 are configured and dimensioned to shape the donor tissue Tinto the donor graft 1 (FIGS. 3, 5, 6) in correspondence with theconfiguration of the recipient site 5 (FIGS. 3-6). For example, in theembodiment of the cutting guide 200 illustrated in FIGS. 15-20, tofacilitate shaping of the donor tissue T in the desired manner, thevanes 224 include a linear portion 228 (FIG. 19), and a non-linearportion 230 defining one or more recesses 232. In the specificembodiment shown, the vanes 224 are illustrated as including a single,curvate recess 232 defining an arcuate surface 234 that extendsinwardly, toward the axis Y, resulting in a generally C-shapedconfiguration. In alternate embodiments, however, the recesses 232 maybe present in greater number, and/or may define alternativeconfigurations. For example, each vane 224 may include a pair ofrecesses 232 that arc triangular in configuration.

Additionally, or alternatively, it is envisioned that the non-linearportion 230 of the vanes 224 may include one or more projections (notshown) extending outwardly, away from the axis Y.

With reference now to FIGS. 15 and 20 in particular, the sled 206 willbe discussed. During operation of the cutting guide 200, the sled 206 isused to stabilize and move the donor tissue T through the channel 208across the lower shelf 214 into contact with the shaping member 204 andonto the upper shelf 216. To facilitate movement of the donor tissue T,the sled 206 is configured and dimensioned to slide in relation to thebody 202 of the cutting guide 200, and may be either fixedly orremovably connected thereto in any manner facilitating movement in thismanner. For example, the sled 206 may rest upon upper surfaces 236, 238(FIG. 15) defined by the sidewalls 210, 212 of the body 202 such thatthe sled 206 slides along the upper surfaces 236, 238 during movement.

In one embodiment, such as the embodiment shown in FIGS. 15 and 20, forexample, the sled 206 includes a shoulder 240 that depends from anunderside 242 (FIG. 20) thereof which may be used to urge the donortissue T into contact with one of the sidewalls 210, 212 (FIG. 15)during movement of the donor tissue T through the channel 208 to furtherstabilize the donor tissue T, e.g., during shaping.

In one embodiment, seen in FIGS. 15 and 20 for example, the underside242 of the sled 206 may include a textured surface 244 to increasefriction between the sled 206 and the donor tissue T, and thus, controlover the donor tissue T during movement through the channel 208. Forexample, the underside 242 of the sled 206 may include one or moreprotrusions 246 configured as detents, teeth, or the like.Alternatively, the underside 242 of the sled 206 may be non-textured.

Additionally, or alternatively, the sled 206 may include retainingstructure (not shown), e.g., one or more pins, clamps, jaws, or thelike, to secure the donor tissue T to the sled 206.

With reference now to FIGS. 3-6 and 15-20, use of the cutting guide 200will be discussed in connection with formation of the aforementioneddonor graft 1.

Initially, the donor tissue T is harvested from a larger section oftissue (not shown), e.g., through use of a saggital saw, scalpel etc.,and is fed into the cutting guide 200. If necessary, the donor tissue Tcan be shaped or trimmed so as to fit within the confines of the channel208 (FIG. 15) defined by the body 202 of the donor implant cutting guide200. Specifically, the donor tissue T is positioned on the lower shelf214, and is stabilized using the sled 206, i.e., the donor tissue T ispositioned between the lower shelf 214 and the sled 206. Using the sled206, the donor tissue T is advanced into contact with the shaping member204 whereby the vanes 224 remove portions of the donor tissue T inaccordance with a pattern determined by the configuration and dimensionsthereof. Specifically, in the illustrated embodiment, the linear portion228 (FIG. 19) of the vanes 224 shape a section of the donor tissue T soas to define a planar section 8 (FIG. 3) that corresponds inconfigurations and dimensions to the upper surface 7 of the recipientsite 5, while the non-linear portion 230 (FIG. 19) of the vanes 224simultaneously shape an adjacent section of the donor tissue T so as todefine a tongue member 9 (FIG. 3). The tongue member 9 corresponds inconfigurations and dimensions to the channel 6 defined by the recipientsite 5, and extends transversely in relation to the length and width ofthe planar section 8 of the donor graft 1 such that the tongue member 9extends outwardly in relation to the planar section 8.

As the donor tissue T passes by the shaping member 204, it is supportedby the upper shelf 216. After shaping of the donor tissue T has beencompleted, i.e., when the donor graft 1 has been formed, the donor graft1 is placed at the recipient site 5 (FIGS. 3-6). Specifically, theplanar section 8 of the donor graft 1 is positioned in abutment with theupper surface 7 of the recipient site 5, and the tongue member 9 ispositioned within the channel 6, as shown in FIGS. 3, 5 and 6, wherebythe donor graft 1 and the recipient site 5 mate in an interlockingfashion so as to inhibit movement of the donor graft 1 in relation tothe recipient site 5, e.g., motion in the medial-lateral direction.

In various embodiments of the present disclosure, the configurations,dimensions, and orientations of the cutting slot 40, the guide hole 50,and the fixation holes 60 of the cutting guide 10 (FIGS. 7-12) may bealtered or varied, as can the configuration and dimensions of the vanes224, the recesses 232, and the shelves 214, 216 of the cutting guide 200(FIG. 15), so as to create a recipient site 5 (FIG. 3) and a donor graft1 that interlock in any desired manner.

With reference again to FIG. 3, following placement of the donor graft1, the donor graft 1 can be attached to the recipient site 5 usingeither temporary or permanent attachment structures (not shown), e.g.,fixation screws, bone plates, or the like.

While the present disclosure has been described in connection withspecific embodiments thereof, it will be understood that the subjectmatter of the present disclosure is capable of further modifications.For example, persons skilled in the art will understand that additionalcomponents and features may be added to any of the embodiments discussedherein above, and that those elements and features described inconnection with any one embodiment may also be applicable to, orcombined with, those of any other embodiment, without departing from thescope of the present disclosure.

The scope of the present disclosure is intended to cover any variations,uses, and/or adaptations of the presently disclosed subject matter inaccordance with the principles of the present disclosure, including suchdepartures from the present disclosure as come within known or customarypractice within the art to which the present disclosure pertains, and asmay be applied to the elements, components, and features set forthherein above.

1. A cutting guide for use in a surgical procedure to remove damagedtissue from a patient and form a recipient site configured anddimensioned to receive a donor graft, the cutting guide comprising: afirst arm configured and dimensioned for abutment with a section of thedamaged tissue to be removed; and a second arm connected to the firstarm, the second arm including at least one slot configured anddimensioned to receive a first cutting implement, and at least one hole,the first arm and the at least one slot defining a distance therebetweencorresponding to a desired dimension of the recipient site.
 2. Thecutting guide of claim 1, wherein the first arm and the second armsubtend an angle approximately equal to 90°.
 3. The cutting guide ofclaim 1, wherein the at least one hole includes a first hole positionedadjacent an end of the at least one slot, the first hole defining aperiphery and being configured and dimensioned to receive a secondcutting implement.
 4. The cutting guide of claim 3, wherein a portion ofthe periphery defined by the first hole is positioned below the at leastone slot.
 5. The cutting guide of claim 4, wherein a portion of theperiphery defined by the first hole is positioned above the at least oneslot.
 6. The cutting guide of claim 5, wherein the at least one slot andthe first hole are oriented such that a central axis defined by the atleast one slot bisects the first hole.
 7. The cutting guide of claim 3,wherein the at least one hole further includes a second hole configuredand dimensioned to receive a fixation member to secure the cutting guidein relation to the damaged tissue.
 8. The cutting guide of claim 1,wherein the at least one slot is linear in configuration.
 9. The cuttingguide of claim 1, wherein the at least one slot includes a first slotand a second slot, the first arm and the first slot defining a firstdistance therebetween, and the first arm and the second slot defining asecond distance therebetween greater than the first distance. 10.-50.(canceled)